Patent Application
20130006536
1. Field of the Invention
The present invention relates, in general, to medical devices and, in particular, to test meters and related methods.
2. Description of Related Art
The determination (e.g., detection and/or concentration measurement) of an analyte in a fluid sample is of particular interest in the medical field. For example, it can be desirable to determine glucose, ketone bodies, cholesterol, lipoproteins, triglycerides, acetaminophen and/or HbA1c concentrations in a sample of a bodily fluid such as urine, blood, plasma or interstitial fluid. Such determinations can be achieved using a hand-held test meter in combination with analytical test strips (e.g., electrochemical-based analytical test strips).
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings, in which like numerals indicate like elements, of which:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict exemplary embodiments for the purpose of explanation only and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.
In general, hand-held test meters for use with an analytical test strip in the determination of an analyte in a bodily fluid sample according to embodiments of the present invention include a housing, a test meter control circuit block (e.g., a microcontroller block), and a Universal Serial Bus (USB) connector block that includes an unpowered USB connection detection circuit block. The unpowered USB connection detection circuit block is configured to provide (i) a shielding signal of a first potential (for example, a high-level signal equal to the hand-held test meter's supply voltage) to the test meter circuit control block in the absence of a USB connection between an external device and the USB connector block and (ii) a shielding signal of a second potential (such as a low-level signal representative of connection to ground) to the test meter control circuit block when a USB connection to an external device (either a powered or an unpowered external device) has been made to the USB connector block. In addition, the test meter control circuit block is configured to interrupt operation of the hand-held test meter when the shielding signal of a second potential is received from the USB connector block.
The general benefits of hand-held test meters according to embodiments of the present invention in detecting both unpowered and powered USB connections will be evident to one skilled in the art based on the following description and reference to
Hand-held test meters according to embodiments of the present invention are beneficial in that they can detect the presence of a USB connection to both unpowered and powered external devices (such as an unpowered external PC or an unpowered external battery charger) and interrupt operation of the hand-held test meter, thus preventing potentially inaccurate analyte determinations.
Once one skilled in the art is apprised of the present disclosure, he or she will recognize that an example of a hand-held test meter that can be readily modified as a hand-hand test meter according to the present invention is the commercially available OneTouch® Ultra® 2 glucose meter from LifeScan Inc. (Milpitas, Calif.). Additional examples of hand-held test meters that can also be modified are found in U.S. Patent Application Publications No's. 2007/0084734 (published on Apr. 19, 2007) and 2007/0087397 (published on Apr. 19, 2007) and in International Publication Number WO2010/049669 (published on May 6, 2010), each of which is hereby incorporated herein in full by reference.
Hand-held test meter 100 includes a display 102, a plurality of user interface buttons 104, a strip port connector 106, a USB connector block 108, and a housing 110 (see
Display 102 can be, for example, a liquid crystal display or a bi-stable display configured to show a screen image. An example of a screen image may include a glucose concentration, a date and time, an error message, an electromagnetic interference detection warning message, and a user interface for instructing an end user on how to perform a test.
Strip port connector 106 is configured to operatively interface with the analytical test strip (not depicted in
Once an analytical test strip is interfaced with hand-held test meter 100, or prior thereto, a bodily fluid sample (e.g., a whole blood sample) is dosed into a sample-receiving chamber of the analytical test strip. The analytical test strip can include enzymatic reagents that selectively and quantitatively transforms an analyte into another predetermined chemical form. For example, the analytical test strip can include an enzymatic reagent with ferricyanide and glucose oxidase so that glucose can be physically transformed into an oxidized form.
Memory block 120 of hand-held test meter 100 includes a suitable algorithm that determines an analyte based on the electrochemical response of the analytical test strip.
As previously described, USB connector block 108 includes an unpowered USB connection detection circuit block 112 (see
Moreover, microcontroller block 114 is configured to interrupt operation of the hand-held test meter when the shielding signal of a second potential is received from the USB connector block. For example, the shielding signal of a second potential can be a shielding signal with a potential representative of connection to ground and the microcontroller block can be configured to sense such a shielding signal of a second potential. In addition, the shielding signal of a first potential can be the hand-held test meter's supply voltage (typically 3V) or other suitable voltage.
If desired, the test meter control circuit block (for example, microcontroller block 114) can further configured to sense a +5V signal from the USB connector block when a USB connection to a powered device has been made to the USB connector block (see
USB connector block 108 includes at five wire connection points, namely (1) +5V supply; (2) D− data line; (3) D+ data line; (4) an unused connection and (5) ground. However, as one of skill in the art will recognize, it is standard for a USB connector block 108 to includes a conductive outer shielding (not depicted in the FIGs.) configured to block electrical noise and for this conductive outer shielding to be electrically connected to a casing of the USB connector block. Connections to this shielding are labeled 8 and 9 in
In the embodiment of
Once apprised of the present disclosure, one skilled in the art will recognize that the unpowered USB connection detection circuit block depicted in
At step 620, method 600 also includes interrupting operation of the hand-held test meter when the shielding signal of a second potential is received by the test meter control circuit block. Such interruption can, for example, include displaying an unpowered USB warning message to a user via a display of the hand-held test meter. In such a scenario, the hand-held test meter's unpowered USB connection detection circuit and test meter control circuit block, as well as a display control block, are configured to control the display of such a warning message.
Methods according to embodiments of the present invention can, if desired, also include the steps of (i) applying a bodily fluid sample to an electrochemical-based analytical test strip; (ii) measuring an electrochemical response of the electrochemical-based analytical test strip using the hand-held test meter; and (iii) determining the analyte based on the measured electrochemical response. Moreover, once apprised of the present disclosure, one skilled in the art will recognize that method 600 can be readily modified to incorporate any of the techniques, benefits and characteristics of hand-held test meters according to embodiments of the present invention and described herein.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that devices and methods within the scope of these claims and their equivalents be covered thereby.
